Bioequivalence study of Dexamethasone 4mg tablet of Abureihan Pharm Co., IRA
Not Applicable
- Conditions
- Inflammatory diseases.
- Registration Number
- IRCT20190706044111N10
- Lead Sponsor
- Aburaihan Pharm Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Aged between 20 - 50 years
Body weight between 50 – 100 kg
Having good health on the basis of medical history and physical & clinical examination
Understand the procedures and give written informed consent.
Exclusion Criteria
Subject showed clinically relevant deviations from normal in physical examination.
Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last 8 weeks before the first treatment.
Subject had a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of dexamethasone. Timepoint: Plasma related to 0, 20, 40 min., 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 10 hr. after dosing. Method of measurement: HPLC.
- Secondary Outcome Measures
Name Time Method